Field of Invention
The invention relating to the apparatus and method of safely inserting a prosthesis into a human body.
Background of the Invention
The present invention is a useful and novel apparatus for simplifying prosthesis implant surgery, such as a breast implant, while preventing inadvertent dislodging of the implant from the distal openings.
Breast implants are a manufactured prosthesis used in cosmetic and reconstructive surgery. A breast implant is gelatinous, having an outer casing or membrane and an inner fluid substance such as saline or silicone.
Most implant procedures today do not use an insertion device. The surgeon makes the incision, creates a pocket for the implant, retracts the incision and then manually pushes the implant into the pocket. A saline implant can be inserted into a pocket in an empty configuration; once placed in the pocket, the implant is then filled with saline solution.
Preferably, the incision in the patient is as short as possible. Shorter incisions are less unsightly. This goal of a shorter incision is easier to accomplish with a saline implant. A saline implant is relatively easy to insert through a short incision, as the bladder is unfilled and therefore small in size as it passes through the incision. In contrast, silicone implants are prefilled resulting in a more difficult and complications-susceptible operation.
The incision is made in one of four places: in the armpit, in the breast fold, in the navel, or around the areola. Except for the navel insertion, one incision is made for each implant. Next, the surgeon dissects a path through the tissue to the desired destination of the implant. Once that path has been created, a pocket is created for the implant superficial or deep to the pectoralis major muscle.
The pocket may be formed in one of two places under the breast: subglandular (between the breast tissue and pectoralis major muscle) or subpectoral (under the pectoralis major muscle). Subglandular places the prosthesis directly behind the mammary gland and in front of the muscle. Subpectoral places the implant partially under the pectoralis major muscle. Due to the structure of the pectoralis major muscle, a portion of the implant is not covered by the muscle.
For inflatable implants, the surgeon rolls up the implant like a cigar and pushes it through the incision and into the pocket. The surgeon then uses a tube to fill the implant with saline.
For pre-filled implants, the procedure requires a larger incision length. The implant is then manually pushed through the incision into the pocket.
Secondary surgeries are common for patients with breast implants. And every additional surgery has risks due to anesthesia, infection or bleeding. In particular, patients with breast implants may require surgery to change the placement (from subglandular to subpectoral or vice versa), correct palpable folding of the implant, remove a ruptured implant; treat infection, bleeding, breast pain, contracted scar tissue forming around the implant and collections of fluid around the implant. The overall complication rate is about 20% for silicone gel breast augmentation with the majority of re-operations related to implant rupture (leakage), bleeding or capsular contracture.
Infection, or Cellulitis, occurs in 2%-4% of patients, with some surgeons reporting much higher rates, and is usually from the bacteria normally present on the skin. Symptoms of infection include fever, pain, swelling and redness. To reduce infection, surgeons give a single dose of antibiotics before the surgery, and use an antibiotic solution in the wound before implant placement. The antibiotic solution may double as lubrication to allow easier insertion of the implant into the pocket. However, surgeons can bring the rate of infection down further by preventing the implant from touching the patient's skin.
The implant insertion devices heretofore known suffer from a number of disadvantages:                1. Requires the surgeon to resize the insertion device to match different implant sizes.        2. Relies on the correct trimming (alteration) by the surgeon. The implant company and insertion device company have no control over the surgeon. If the surgeon does not alter the device properly, unsafe damaging pressure may be applied to the implant during the insertion process.        3. Distal end of the device is large enough for the implant to inadvertently slip out of the device.        4. Due to the high cost, encourages re-use despite the manufacturer recommendation not to do so.        